Device Classification Name |
system, nuclear magnetic resonance imaging
|
510(k) Number |
K092253 |
Device Name |
MODIFICATION TO FMRI HARDWARE SYSTEM |
Applicant |
NORDICNEUROLAB |
MOLLENDALSVEIEN 65C |
BERGEN,
NO
N-5009
|
|
Applicant Contact |
CHANDANA GURUNG BHANDARI |
Correspondent |
NORDICNEUROLAB |
MOLLENDALSVEIEN 65C |
BERGEN,
NO
N-5009
|
|
Correspondent Contact |
CHANDANA GURUNG BHANDARI |
Regulation Number | 892.1000
|
Classification Product Code |
|
Date Received | 07/28/2009 |
Decision Date | 10/08/2009 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|